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TWI455723B - Use of naltrexone and bupropion for treating overweight or obese patients - Google Patents

Use of naltrexone and bupropion for treating overweight or obese patients Download PDF

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Publication number
TWI455723B
TWI455723B TW095143283A TW95143283A TWI455723B TW I455723 B TWI455723 B TW I455723B TW 095143283 A TW095143283 A TW 095143283A TW 95143283 A TW95143283 A TW 95143283A TW I455723 B TWI455723 B TW I455723B
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naltrexone
bupropion
dose
unit dosage
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TW095143283A
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Chinese (zh)
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TW200803900A (en
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Anthony A Mckinney
Gary Tollefson
Michael A Cowley
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Orexigen Therapeutics Inc
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/485—Morphinan derivatives, e.g. morphine, codeine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/136—Amines having aromatic rings, e.g. ketamine, nortriptyline having the amino group directly attached to the aromatic ring, e.g. benzeneamine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/138—Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/13—Amines
    • A61K31/15—Oximes (>C=N—O—); Hydrazines (>N—N<); Hydrazones (>N—N=) ; Imines (C—N=C)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/34—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide
    • A61K31/343—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide condensed with a carbocyclic ring, e.g. coumaran, bufuralol, befunolol, clobenfurol, amiodarone
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    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
    • A61K31/351—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom not condensed with another ring
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    • A61K31/33—Heterocyclic compounds
    • A61K31/38—Heterocyclic compounds having sulfur as a ring hetero atom
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    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4164—1,3-Diazoles
    • A61K31/4166—1,3-Diazoles having oxo groups directly attached to the heterocyclic ring, e.g. phenytoin
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/42—Oxazoles
    • A61K31/423—Oxazoles condensed with carbocyclic rings
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445—Non condensed piperidines, e.g. piperocaine
    • A61K31/451—Non condensed piperidines, e.g. piperocaine having a carbocyclic group directly attached to the heterocyclic ring, e.g. glutethimide, meperidine, loperamide, phencyclidine, piminodine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445—Non condensed piperidines, e.g. piperocaine
    • A61K31/4523—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems
    • A61K31/4525—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a five-membered ring with oxygen as a ring hetero atom
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • A61K31/551—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having two nitrogen atoms, e.g. dilazep
    • A61K31/5513—1,4-Benzodiazepines, e.g. diazepam or clozapine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/04—Anorexiants; Antiobesity agents

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  • Diabetes (AREA)
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  • Obesity (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Child & Adolescent Psychology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Coloring Foods And Improving Nutritive Qualities (AREA)
  • Other Investigation Or Analysis Of Materials By Electrical Means (AREA)

Claims (6)

一種納曲酮(naltrexone)及安非他酮(bupropion)之用途，其係用以製備用於治療超重或肥胖病患之藥物，其中該治療包含：在第一治療期間內每日口服投予包含第一量之納曲酮及安非他酮之藥物至該病患，其中該第一治療期間係至少三天，且其中該第一量之納曲酮及安非他酮為每日投予一次；在第二治療期間內每日口服投予包含第二量之納曲酮及安非他酮之藥物至該病患，其中該第二量包含第一量之納曲酮之兩倍量及第一量之安非他酮之兩倍量，其中該第二治療期間係至少四天，且其中該第二量之納曲酮及安非他酮為以兩個相等之每日劑量投予；在第三治療期間內每日口服投予包含第三量之納曲酮及安非他酮之藥物至該病患，其中該第三量包含第一量之納曲酮之三倍量及第一量之安非他酮之三倍量，其中該第三治療期間係至少一週，其中該第三量之納曲酮及安非他酮為以兩個每日劑量投予，一劑量包含每日劑量之2/3，且另一劑量包含每日劑量之1/3；及在第四治療期間內每日口服投予包含第四量之納曲酮及安非他酮之藥物至該病患，其中該第四量包含第一量之納曲酮之四倍量及第一量之安非他酮之四倍量，其中該第四量之納曲酮及安非他酮為以兩個相等之每日劑量投予； 其中納曲酮係持續釋放形式，其中安非他酮係持續釋放形式，且其中該第一量之安非他酮為90mg，且其中該第一量之納曲酮為4mg或5mg至10mg。 A use of naltrexone and bupropion for the preparation of a medicament for treating a patient who is overweight or obese, wherein the treatment comprises: daily oral administration during the first treatment period a drug comprising a first amount of naltrexone and bupropion to the patient, wherein the first treatment period is at least three days, and wherein the first amount of naltrexone and bupropion is daily Once a day; orally administering a second dose of naltrexone and bupropion to the patient during the second treatment period, wherein the second amount comprises twice the first amount of naltrexone And twice the amount of the first amount of bupropion, wherein the second treatment period is at least four days, and wherein the second amount of naltrexone and bupropion are in two equal daily doses Administering a daily dose of a third dose of naltrexone and bupropion to the patient during the third treatment period, wherein the third amount comprises three times the first amount of naltrexone And a third amount of the first amount of bupropion, wherein the third treatment period is at least one week, wherein the third amount is And bupropion are administered in two daily doses, one dose comprising 2/3 of the daily dose, and the other dose comprising one third of the daily dose; and daily oral administration during the fourth treatment period a fourth dose of naltrexone and bupropion to the patient, wherein the fourth amount comprises four times the first amount of naltrexone and four times the first amount of bupropion A quantity wherein the fourth amount of naltrexone and bupropion are administered in two equal daily doses; Wherein the naltrexone is in a sustained release form, wherein the bupropion is in a sustained release form, and wherein the first amount of bupropion is 90 mg, and wherein the first amount of naltrexone is 4 mg or 5 mg to 10 mg. 如請求項1之用途，其中該第一量之納曲酮及安非他酮係呈單一單位劑型。 The use of claim 1, wherein the first amount of naltrexone and bupropion are in a single unit dosage form. 如請求項1之用途，其中該第一量之納曲酮係呈單一單位劑型且該第一量之安非他酮係呈單一單位劑型。 The use of claim 1, wherein the first amount of naltrexone is in a single unit dosage form and the first amount of bupropion is in a single unit dosage form. 如請求項1之用途，其中該第一量之納曲酮及安非他酮係呈單一單位劑型，其中該第二量之納曲酮及安非他酮係呈兩個單一單位劑型，其中該第三量之納曲酮及安非他酮係呈三個單一單位劑型，且其中該第四量之納曲酮及安非他酮係呈四個單一單位劑型。 The use of claim 1, wherein the first amount of naltrexone and bupropion are in a single unit dosage form, wherein the second amount of naltrexone and bupropion are in two single unit dosage forms, wherein The third amount of naltrexone and bupropion are in three single unit dosage forms, and wherein the fourth amount of naltrexone and bupropion are in four single unit dosage forms. 如請求項1之用途，其中該第一量之納曲酮為4mg。 The use of claim 1, wherein the first amount of naltrexone is 4 mg. 如請求項1之用途，其中該第一量之納曲酮為5mg至10mg。The use of claim 1, wherein the first amount of naltrexone is from 5 mg to 10 mg.
TW095143283A 2005-11-23 2006-11-22 Use of naltrexone and bupropion for treating overweight or obese patients TWI455723B (en)

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